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Thread: FDA approval timelines

  1. #1

    FDA approval timelines

    Is anyone aware of the timeline the FDA is under to approve an IND? I conducted some quick research and was unable to find conclusive deadlines. For example, I know that In Vivo Therapeutics submitted an application to the FDA several months ago and I'm wondering when they will receive word. Any quick thoughts?

  2. #2
    Hi Chaz!
    It is my understanding that the FDA has 60 days to respond to an IND request. At the end of that time period, they are required to respond. Their response may be that they require another 60 days. After another 60 days, they might come back asking for another 60 days.

    There is no telling how long it will be before your IND request is approved or you receive an answer as to why it isn't.
    "Our lives begin to end the day
    we become silent about things that matter."
    - Martin Luther King Jr

  3. #3
    Thanks, Donna! So The communication between the FDA and biotech companies remains confidential? I may be wrong, but are the following companies awaiting approval: invivo therapeutics, neuralstem, Miami project?

  4. #4
    Chaz, I spoke with the Miami Project and they are indeed waitin for approval for their Schwaan Cell therapy. they responded as such:
    We do not know when the phase 1 Schwann cell trial will begin, that depends on the FDA. We are following the Geron trial very closely and are supportive of it. Wise Young’s trial is in China and is not FDA approved. We are following what information we can find.
    Best wishes,

    ----- Original Message -----

    From: Miami Project Information

    Sent: Thursday, December 09, 2010 8:01 AM

    Subject: RE: question

    Hi Tony,
    Yes, Schwann cells do remyelinate demyelinated axons. Our initial goal is to evaluate their safety and efficacy in SCI. They may be beneficial to MS later.

    Kim Anderson-Erisman, Ph.D.
    Director of Education
    The Miami Project to Cure P

    Last edited by keeping on; 12-20-2010 at 10:43 AM.

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